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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceOPTIMIZER Smart System
Generic NameImplantable pulse generator
ApplicantImpulse Dynamics (Usa), Inc.
50 Lake Center Executive Pkwy.
401 Rte. 73 N, Bldg. 50 Suite 100
Marlton, NJ 08053
PMA NumberP180036
Supplement NumberS037
Date Received12/20/2024
Decision Date03/18/2025
Product Code QFV 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for implantable pulse generator firmware version 1.16.0 to implement bug fixes and additional improvements
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